Identity
- Trade Name
- Apollo Duet FDA UDI
- Generic Name
- Radio-frequency physical therapy system FDA UDI
- Device Name
- Pain management device with multipolar RF FDA UDI
- Model / Reference
- ADP-4000 FDA UDI
- Description
- Pain management device with multipolar RF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809851470015 FDA UDI
- 510(k) Number
- K212253 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Radio-frequency physical therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency physical therapy system
Apollo Duet by Weero Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency physical therapy system.
- ZShape — Zimmer MedizinSysteme GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Weero Co., Ltd.
Sources (1)
- FDA UDI c4093711-6a6a-45cf-9d79-345e0273985e 34 fields · synced Jun 8, 2026